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EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on the model). These optical properties are to be examined and reviewed in this trial (mainly usability and safety)
EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a 330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this study is to evaluate the safety, performance and usability of additional versions of FSOT- powered gastroscopes and colonoscopes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopy exploratory single arm | Experimental | Exploratory single arm, the system will be used in otherwise standard procedures, and will be reviewed in terms of performance, usability, ease of use and safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy exploratory single arm (EndoChoice FUSE(TM) System) | Device | The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Performance, usability and ease of use | The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The safety of the device will be assessed as a secondary outcome measure according to quantity and nature of adverse and severe adverse events, if such occur. | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Gralnek, Prof. | Rambam Medical Center Gastroenterological institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam medical center | Haifa | Israel | 31096 | Israel |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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